Identity
- Trade Name
- Hysteroscopic Fluid Management FDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Device Name
- RFB CU HYSTER FLUID MGMT SYSTEM FDA UDI
- Model / Reference
- 7210164F FDA UDI
- Description
- RFB CU HYSTER FLUID MGMT SYSTEM FDA UDI
Identifiers
- Catalog Number
- 7210164F FDA UDI
- Primary DI / UDI-DI
- 00885556570487 FDA UDI
- 510(k) Number
- K031616 FDA UDI
- FDA Product Code
- HIG FDA UDI
- GMDN Term
- Surgical irrigation tubing set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical irrigation tubing set, single-use
Hysteroscopic Fluid Management by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation tubing set, single-use.
- SuperFlow Tubing Set — ARMM INC. · Class II
- Irrigation Set — B. BRAUN MEDICAL INC. · Class II
- EndoGator Hybrid — MEDIVATORS INC. · Class II
- IPC™ Visao® — MEDTRONIC XOMED, INC. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- CODMAN® — Integra LifeSciences Switzerland Sàrl · Class II
- MIDAS REX MR8 — Medtronic Powered Surgical Solutions · Class II
- Endo-Flo — Davol Inc. · Class II
Cleared under the same submission
K031616 also covers:
- Hysteroscopic Fluid Management — Smith & Nephew, Inc.
- Hysteroscopic Fluid Management — Smith & Nephew, Inc.
- Hysteroscopic Fluid Management System Stand — Smith & Nephew, Inc.
- Hysteroscopic Inflow Tube Set — Smith & Nephew, Inc.
- Hysteroscopic Outflow Tube Set — Smith & Nephew, Inc.
- Hysteroscopic Roller Base — Smith & Nephew, Inc.
- TRUCLEARTM — Smith & Nephew, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI c301d057-a0fe-4297-b12f-43f824c15334 36 fields · synced Jun 8, 2026